PMA P080012S013
- Device
- PROMERA PROGRAMMABLE INFUSION PUMP SYSTEM
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S013
- Product code
- LKK
- Decision date
- 2013-06-03
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- APPROVAL FOR ADDING AN ALTERNATE SUB-TIER SUPPLIER AND MATERIAL CHANGE FOR THE MOLDED SILICONE SUTURE WINGS (STRAIGHT AND 90 DEGREE) THAT ARE SUPPLIED IN THE CATHETER KIT.
Current openFDA PMA Record#
- Device
- PROMERA PROGRAMMABLE INFUSION PUMP SYSTEM
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S013
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2013-06-03
- Decision code
- APPR
- Date received
- 2013-03-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR ADDING AN ALTERNATE SUB-TIER SUPPLIER AND MATERIAL CHANGE FOR THE MOLDED SILICONE SUTURE WINGS (STRAIGHT AND 90 DEGREE) THAT ARE SUPPLIED IN THE CATHETER KIT.